Kornimate/medical-research-clean huggingface dataset:
prothrombin complex concentrate vs fresh frozen plasma in goal-directed bleeding management in non-cardiac surgery

Conditions: Prostate Cancer; Spine, Open; Hip Osteoarthritis; Knee Disease

Summary: the primary endpoint of this study is the completion time of hemostasis treatment when administered fresh frozen plasma (ffp) and frozen powder coagulation factor concentrate (pcc) in goal-directed bleeding management for non-cardiac surgery.


Eligibility criteria:
inclusion criteria: * patients undergoing spine surgery * patients undergoing open radical prostatectomy * patients undergoing hip arthroplasty * patients undergoing knee arthroplasty exclusion criteria: * patients taking oral anticoagulants, * patient taking recombinant factor vii a * pregnancy
nurse-led, symptom-based screening of household child contacts of tuberculosis index cases

Conditions: Tuberculosis

Summary: to assess implementation of a nurse-led, symptom-based screening program in local, decentralized clinics for tuberculosis (tb) screening of child contacts less than 5 years old who were exposed to tuberculosis in the home. this will allow nurses in decentralized clinics to either start ipt for those asymptomatic patients and refer symptomatic patients for evaluation of tb disease and possible antituberculous therapy (att).

retrospective review of routine program data for child contacts less than five years of adult tb index cases who are receiving tb care at local, decentralized clinics in the matlosana district of northwest province will be assessed. 16 clinics will be stratified and randomized in 1:1 fashion to either tst-based screening, the current standard of care, or symptom-based screening, the newly recommended standard of care in south africa. those who are tst positive in the tst-based group and those who are symptomatic in the symptom-based group will be referred to klerkdorp hospital for further evaluation of tuberculosis. nurses in the decentralized clinics will initiate those who are tst negative or asymptomatic on ipt. their clinical course will be monitored throughout treatment and adherence to therapy measured. the investigators will compare clinic-level outcomes including percentage of patients initiated on, adherent to, and completing ipt.

Eligibility criteria:
inclusion criteria: * child less than five years old * household contact of a drug-sensitive pulmonary or extrapulmonary tb index case (drug sensitivity is define as culture-confirmed or absence of rifampin resistance on gene xpert) admitted to one of the public clinics in the matlosana sub-district on or after october 1, 2015. exclusion criteria: * household contact of a drug-resistant tb index case. (drug resistance defined either by culture or by presence of rifampin resistance on gene xpert).
a study to compare the effects of improving the carotid artery intima media thickness and changing lipid levels by cilostazol/ginkgo leaf extract and aspirin in diabetic peripheral angiopathy.

Conditions: Diabetic Peripheral Angiopathy

Summary: this study is to compare and evaluate the effect of improving the carotid imt and lipid level of the cilostazol/ginkgo leaf extract group with the aspirin administrated group in patients with diabetic peripheral angiopathy.

a prospective, randomized, active-controlled, parallel, open, multi-center, phase iv

Eligibility criteria:
\ 1. male or female aged between 20 years and 75 years(inclusive) 2. patients who diagnosed as type 2 diabetes and diabetic peripheral angiopathy 3. patients with a maximum intra-carotid membrane thickness (maximum imt) of 0.9 mm or more among the thickest areas, including plaques, in the cca, ica, and bulb three areas of the carotid artery \ 1. patients who diagnosed with type 1 diabetes, secondary diabetes, or gestational diabetes 2. patients with cerebrovascular or cardiovascular complications within 6 months of screening (cerebral infarction, transient ischemic seizures, myocardial infarction, unstable angina, coronary artery bypass graft(cabg), pci, etc.) 3. patients with bleeding (hemophilia, capillary weakness, intracranial hemorrhage, upper digestive tract hemorrhage, urinary tract hemorrhage, hematopoietic hemorrhage, active digestive ulcers, etc.) or peptic ulcers within 3 months of screening 4. patient who took anticoagulants, antiplatelet drugs including aspirin, cilostazol, thrombolytic agents, prostaglandin e1 and glucagon-like peptide -1 (glp-1) receptor agonist within 2 weeks of the baseline
a study to evaluate the mechanism of action of cp-690,550 in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: to explore the effect of cp-690,550 on blood and synovial markers in subjects with rheumatoid arthritis. to evaluate the safety, tolerability and efficacy of cp-690,550.


Eligibility criteria:
inclusion criteria: * subject must have a diagnosis of rheumatoid arthritis based on the american college of rheumatology association * the subject has active disease at both screening and baseline, as defined: * ≥4 joints tender or painful on motion, and * ≥4 joints swollen; * the subject must have at least one knee, one elbow, one wrist or two metacarpophalangeal joints with active synovitis suitable for biopsy by the shaver technique exclusion criteria: * no arthroscopy should have been performed in the past 3 months in the same joint that is to be biopsied in this study. * no intra-articular steroids should have been injected in the joint to be biopsied in this study in the previous 3 months. * subjects with evidence of hematopoietic disorders or evidence of hemoglobin levels \< 9.0 gm/dl or hematocrit \< 30 % at screening visit or within the 3 months prior to baseline synovial biopsy. * an absolute white blood cell (wbc) count of \< 3.0 x 109/l (\<3000/mm3) or absolute neutrophil count of \<1.2 x 109/l (\<1200/mm3) at screening visit or within the 3 months prior to baseline synovial biopsy. * thrombocytopenia, as defined by a platelet count \<100 x 109/l (\< 100,000/mm3) at screening visit or within the 3 months prior to baseline synovial biopsy. * estimated gfr less than 40 ml/min based on cockcroft gault calculation .
effects of weekly hippotherapy frequency on children with cerebral palsy

Conditions: Cerebral Palsy

Summary: the hippotherapy is considered a therapeutic modality that provides numerous benefits in the rehabilitation process and has often been recommended by doctors for children with cerebral palsy. despite being in frank ascent, this therapy still lacks scientific evidence. objectives: to analyze and compare the effects of hippotherapy program, often 1 or 2 days a week in gross motor function, trunk balance and functional performance of children with cerebral palsy.

study characterized by a controlled experiment with a sample of 24 children, aged between 2 and 4 years, were randomly divided into control group (cg), with 9 participants, with the use of 1 to week and experimental group, also with 11 participants, 2 times a week intervention. the call followed protocol and took place once or twice a week lasting 30 minutes.

Eligibility criteria:
inclusion criteria: * children from 2 to 6 years of age with diagnosis of cerebral palsy, besides medical, physiotherapeutic and psychological referral with indication of the practice of hippotherapy * children classified with gmfcs levels 2, 3, 4 or 5 * understanding, agreement and signing of the free and informed consent form * understanding, agreement and signing of the free and informed assent term, when applicable * possibility to participate in a riding program 1 or 2 times a week for a period of 16 weeks * conduct traditional physiotherapy concomitantly 1 or 2 times a week exclusion criteria: * presence of associated syndromes or structural deformities that make hippotherapy impossible * present seizures without medication control * does not have enough hip joint amplitude for riding (about 20 degrees of abduction) * to have an invasive or surgical procedure during the study * have previously participated in an equine therapy program

Keywords: hippotherapy gross motor function functional performance.
study to determine the pharmacokinetics and pharmacodynamic effects of phenylephrine on bp via iv

Conditions: Hypotension

Summary: the primary objective of this study is to evaluate the dose effect of phenylephrine hydrochloride injection on the treatment of clinically relevant decreased blood pressure in the pediatric population, ≥12 to 16 year old patients undergoing general and neuraxial anesthesia. the secondary objectives are to describe changes in blood pressure and heart rate, time to onset and to maximal response, and the duration of response; to assess the safety of the product in this population; and to characterize the pharmacokinetics of phenylephrine hydrochloride.

this is a phase 4 multi-center, randomized open-label study in 100 subjects aged ≥12 to 16 years who experience a decrease in blood pressure during a procedure requiring general or neuraxial anesthesia. at least 300 subjects will be enrolled in this study. it is anticipated that up to 33% of enrolled subjects will actually experience a decrease in blood pressure that requires treatment and so will receive phenylephrine hydrochloride injection (phi). there are 12 possible randomization assignments: one of six initial treatments phi will be initially administered to approximately 50 subjects as an intravenous bolus (iv-b) at low (1 μg/kg), med (3 μg/kg), or high (5 μg/kg) level; phi will be initially administered to approximately 50 subjects as a continuous intravenous infusion (iv-i) at low (0.25 μg/kg/min), med (0.75 μg/kg/min), or high (1.25 μg/kg/min) level\]; each initial treatment group will have two pharmacokinetics (pk) sampling schedules.

Eligibility criteria:
inclusion criteria: 1. subject's age is between ≥12 and 16 years, inclusive 2. subject is scheduled for a procedure that requires general or neuraxial anesthesia 3. subjects must have normal or clinically acceptable physical exam 4. subjects with controlled diabetes prior to entry must have a mean systolic/diastolic office blood pressure ≤128/78 mmhg (sitting, after 5 minutes of rest) 5. females must have a urine or serum pregnancy test (human chorionic gonadotropin) that is negative at screening and day 1 6. subject's parent or legal guardian gives informed consent and subject gives assent. exclusion criteria: 1. subject has a contraindication to vasoconstrictor therapy for control of blood pressure 2. subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment 3. subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures 4. subjects who have a history of any clinically significant local or systemic infectious disease within four weeks prior to initial treatment administration 5. subjects who are positive for hepatitis b surface antigen or hepatitis c antibody 6. subjects taking antihypertensive medication 7. subject is moribund (death is likely to occur in less than 48 hours) 8. females who are pregnant, nursing or unwilling to use/practice adequate contraception.
changed serum levels of sirtuin1 and sirtuin3 and their correlations with sleep quality and cognitive function in the patients with chronic insomnia disorder

Conditions: Chronic Insomnia Disorder

Summary: the goal of this study is to explore whether mitochondrial dysfunction exists in patients with chronic insomnia disorder. the main questions it aims to answer are : * do serum mitochondrial markers change in patients with chronic insomnia? * is there a relationship between serum mitochondrial markers and sleep and cognition in patients with chronic insomnia disorder? the researchers will compare serum mitochondrial marker levels among participants in the chronic insomnia group with those in the healthy group, and analyze the relationship between the markers and sleep and cognition of the participants. participants will: * complete polysomnography, the pittsburgh sleep quality index (psqi), the chinese-beijing version of the montreal cognitive assessment (moca-c), the blue velvet arena test (bvat), the nine box maze test (nbmt) to assess sleep and cognition. * the venous blood was drawn to detect mitochondrial marker levels.


Eligibility criteria:
inclusion criteria: * meet the diagnostic criteria of the third edition of the international classification of sleep disorders,26 at the same time, meet the following requirements: ① duration suffered form insomnia \> 6 months; ② 18-60 years old; ③ receiving education ≥ 9 years of, without any understanding and hearing impairment; ④ the pittsburgh sleep quality index (psqi) \> 7 sores, hamilton anxiety scale-14 (hama-14) \< 14 scores, the patient health questionnaire-9 (phq-9) \< 10 scores; ⑤ there was no history of any sedative and hypnotic drugs in the two weeks prior to the visit exclusion criteria: * patients during pregnancy or breastfeeding or patients who have taken sedative hypnotic drugs or any other drugs that may affect sleep, mood and cognitive function within two weeks were not eligible for the study.
case series assessing tissuglu® surgical adhesive in flap surgery for decubitus repair

Conditions: Decubitus Ulcer

Summary: to evaluate the impact of a high strength lysine-based adhesive (tissuglu® surgical adhesive) on complications and revision rates in large flap surgery for decubitus repair.

a total of 50 subjects undergoing flap surgery for decubitus repair at the clinic for plastic and aesthetic surgery, hand surgery, st. joseph's hospital in hagen, germany were included in a post-market investigator initiated, retrospective observational series study.

Eligibility criteria:
inclusion criteria: * undergoing a procedure for decubitus repair * be 22 years of age or older exclusion criteria: * expected flap size less than 5 sqcm
the effect of liraglutide treatment on postprandial chylomicron and vldl kinetics, liver fat and de novo lipogenesis

Conditions: Type 2 Diabetes

Summary: this study aims to evaluate the mechanisms underlying the effect of incretin therapy on lipoprotein metabolism in subjects with type 2 diabetes and to study the effect of liraglutide on hepatic de novo lipogenesis.

the well recognized dyslipidemia in people with type 2 diabetes consists of high fasting and non-fasting plasma triglycerides (tg), low high-density lipoprotein (hdl) -cholesterol and preponderance of small dense low-density lipoprotein (ldl) particles nominated as the atherogenic lipid triad. humans are mostly in a postprandial rather than fasting state and therefore non-fasting tg values reflect more accurately the continuous exposure of arterial wall to triglyceride rich lipoproteins (trls) and more importantly, to substantial cholesterol load that these particles deliver. postprandial lipemia is highly prevalent even in type 2 diabetes patients with normal fasting tg concentrations. intestinal overproduction of chylomicrons (cms) and the structural protein apolipoprotein (apo)-b48 has been identified as an integral feature of postprandial lipemia in type 2 diabetes and insulin resistance. it is clinically important to elucidate the mechanism for delayed postprandial lipemia and the interactions between dysglycemia and dyslipidemia in type 2 diabetes patients.

Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes treated with a lifestyle or metformin (any dose) * waist circumference \> 88 cm in women and \> 92 cm in men * bmi 27-40 kg/m2 * triglycerides between 1.0 - 4.0 mmol/l * ldl \< 4.5 mmol/l exclusion criteria: * type 1 diabetes * apo e2/2 phenotype * alt/ast \> 3x uln * gfr \< 60 ml/min, clinically significant tsh outside normal range * lipid-lowering drugs other than statins within 6 months * current treatment with pioglitazone, insulin, sulphonylureas, gliptins, glinides, sglt-2 inhibitors or thiazide diuretics (at a dose of \> 25 mg / day) * blood pressure \> 160 mmhg systolic and/or \> 105 diastolic * history of pancreatitis or stomach / other major bleeding, thyroid neoplasia, persistent hypothyroidism or persistent hyperthyroidism * any medical condition that puts the patient in the risk of dehydration * concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study. * females of childbearing potential who are not using adequate contraceptive methods * subjects who have experienced side-effects previously from glp-1 agonists * non-compliance or withdrawal of consent * any information or clinical event described in liraglutide spc that is a contraindication for the use of liraglutide
use of interlocking detachable coils system in embolization of peripheral arterial embolization

Conditions: Peripheral Arterial Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of interlocking detachable coils system in the treatment of chinese patients with embolization of peripheral arterial in comparison with interlock fibered idc occlusion system

this is a prospective, multicenter, open-label, non-inferiority, randomized controlled clinical trial. the plan is to recruit patients with peripheral arterial disease requiring embolization and then perform peripheral arterial embolization based on randomization using devices in the experimental group or control group. this trail will be conducted in a number of experimental institutions in china, and a total of 116 subjects are planned to be enrolled. all subjects were treated with the interlocking detachable coils system and were evaluated during surgery and before discharge from the treatment of experimental or control devices, followed up at 1 month, 3 months, and 6 months after surgery.

Eligibility criteria:
inclusion criteria: 1. age 18-80 years; 2. subject diagnosed with peripheral arterial embolization by preoperative imaging (cta); 3. the target vessel can be embolized in one operation; 4. the visual diameter of the target blood vessel is 5mm-30mm; 5. subjects or their legal representatives can understand the purpose of the trial, voluntarily participate and sign the written informed consent, and can be followed up. exclusion criteria: 1. definite allergy, resistance or contraindication to antiplatelet agents, anticoagulants, contrast agents and/or anesthetics; 2. definite allergy to platinum, tungsten and/or any substance in the test coil; 3. subjects are not suitable for anesthesia or endovascular surgery, such as those with severe respiratory, heart, lung, liver, kidney disease or coagulation disorders (such as hemophilia); 4. the target vessel has undergone previous surgery and/or major cardiovascular surgery within 3 months; 5. the target aneurysm is dissecting aneurysm, infected aneurysm, ruptured aneurysm, and aneurysm caused by connective tissue disease; 6. women who are pregnant or breastfeeding; 7. subjects who are participating in clinical trials of other drugs or devices that have not reached the end point of the trial; 8. the researcher believes that it is not suitable to participate in the trial.

Keywords: peripheral arterial disease
s9715, chemotherapy and radiation therapy in treating patients with advanced cancer of the nasopharynx

Conditions: Head and Neck Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with advanced cancer of the nasopharynx.

objectives: i. gather additional information and experience regarding the preferred treatment from clinical trial swog-8892, chemoradiation for patients with advanced nasopharyngeal cancers (npc). ii. evaluate survival and progression-free survival and patterns of tumor failure in this new group of patients. iii. assess severe or lethal toxicities that may be encountered after this regimen is employed more widely. iv. collect npc tumor specimens for ongoing and future clinical correlative research. outline: patients receive cisplatin by intravenous infusion on day 1 over a 15-20 minute period. this is repeated every 21 days for the first three initial treatments. patients also receive radiation therapy once daily five times a week during this cycle of treatment. approximately three weeks after completion of the above treatment, patients are given cisplatin by intravenous infusion over 15-20 minutes as above but at a lower dose. on the same day as cisplatin infusion, patients receive fluorouracil by continuous intravenous infusion over 24 hours for 4 days in a row. this is repeated every 28 days for a total of 3 treatments. patients are followed until death. projected accrual: 100 patients will be accrued.

Eligibility criteria:
disease characteristics: histologically proven nasopharyngeal carcinoma (excluding adenocarcinoma), stage iii or iv with no evidence of distant metastatic disease (m0) no lung, bone, or liver metastases as proven within 42 days of registration by: -ct scan or nucleotide study of the chest or chest x-ray -liver and bone scan if alkaline phosphatase is greater than the institutional upper limit of normal (uln), or if clinically indicated -liver scan if sgot is greater than the institutional uln patient characteristics: age: any age performance status: swog 0-2 life expectancy: not specified hematopoietic: absolute granulocyte count at least 1,500/mm3 platelet count at least 75,000/mm3 hepatic: not specified renal: creatinine no greater than 1.6 mg/dl and/or creatinine clearance at least 50 ml/minute other: not pregnant or nursing women/men of reproductive potential must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: no previous chemotherapy to the primary site or nodes endocrine therapy: not specified radiotherapy: no previous radiotherapy (except for nonmelanomatous skin cancer outside of the radiation therapy treatment volume) surgery: no previous surgery to the primary site or nodes

Keywords: stage iii nasopharyngeal cancer stage iv nasopharyngeal cancer
a study comparing the effects of famotidine pretreatment and of food on the relative bioavailability of bms-986165 in healthy volunteers

Conditions: Healthy Participants

Summary: the primary purpose of this study is to evaluate the effects of food and ph on the relative bioavailability (ba) of the tablet formulation of bms-986165 in healthy volunteers


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * body mass index of 18.0 kg/m\^2 to 32.0 kg/m\^2, inclusive, and body weight ≥ 50 kg, at screening * male and female paritcipants, aged 18 years, or age of majority, to age 55 years, inclusive * all female subjects must have a negative serum or urine pregnancy test exclusion criteria: * any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease. * history of administration of live vaccines within 60 days before screening until clinic discharge * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg, or clinical laboratory determinations beyond what is consistent with the target population other protocol-defined inclusion/exclusion criteria could apply